Data / FDA device clearances / Minnesota

FDA device clearances in Minnesota: 1,513 since Nov 2024

Name: FDA device clearances for applicants in Minnesota
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The full list. FDA device clearances for applicants in Minnesota: 1,513 rows for $75.65, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 50 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/state/minnesota, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 1,513 device decisions for applicants in Minnesota from November 12, 2024 to October 30, 2026: 153 510(k) clearances and De Novo grants and 1,360 PMA approvals and supplements, for 92 applicants. The newest, P960009/S548 on October 30, 2026, is Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense from Medtronic, Inc..

The request: Every new FDA device clearance or approval for a company in Minnesota, with its address, the device and the product code. $10 of credit on sign-up, no card.

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SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

1,513Decisions
153510(k) and De Novo
1,360PMA
October 30, 2026Latest decision

Newest decisions

The newest 100 of 1,513, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

Decision date	Number	Device	Applicant	Location	Decision	Type	Product code	Source
October 30, 2026	P960009/S548	Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	MHY	accessdata.fda.gov
October 30, 2026	P860004/S465	SynchroMed Infusion System, Ascenda Intrathecal Catheters	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	LKK	accessdata.fda.gov
October 30, 2026	P840001/S636	Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces-Quad...	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	LGW	accessdata.fda.gov
October 30, 2026	P200026/S020	Abre Venous Self-expanding Stent System	Medtronic Vascular, Inc.	Minnesota	Approved	PMA special supplement	QAN	accessdata.fda.gov
October 29, 2026	P980035/S849	Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S...	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	NVZ	accessdata.fda.gov
October 29, 2026	P980016/S967	Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD	Medtronic Cardiac Rhythm Disease Management	Minnesota	30-day notice accepted	PMA 30-day notice	LWS	accessdata.fda.gov
October 29, 2026	P970004/S460	InterStim Therapy System, Verify Evaluation System (SNS Urinary Neurostimulator 97800), (SNS Urinary...	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	EZW	accessdata.fda.gov
October 29, 2026	P960009/S547	Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (DBS Neurostimulator Implantable...	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	MHY	accessdata.fda.gov
October 29, 2026	P860004/S464	SynchroMed Infusion System, Ascenda Intrathecal Catheters TDD (Drug Delivery Infusion Pump 8667), TDD (Drug...	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	LKK	accessdata.fda.gov
October 29, 2026	P840001/S635	Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces...	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	LGW	accessdata.fda.gov
October 29, 2026	P190023/S033	Navitor Transcatheter Aortic Valve Implantation System	Abbott Medical	Minnesota	Approved	PMA 180-day supplement	NPT	accessdata.fda.gov
October 29, 2026	P080025/S354	InterStim Therapy System, Verify Evaluation System (SNS Bowel Neurostimulator 97800), (SNS Bowel...	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	QON	accessdata.fda.gov
October 29, 2026	P010031/S934	Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D	Medtronic Cardiac Rhythm Disease Management	Minnesota	30-day notice accepted	PMA 30-day notice	NIK	accessdata.fda.gov
October 29, 2026	P010015/S592	Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara...	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	LWP	accessdata.fda.gov
October 29, 2026	K263648	Vitrea Advanced Visualization, Version 7.16	Canon Medical Informatics, Inc.	Minnesota	Substantially Equivalent	510(k) special	LLZ	accessdata.fda.gov
October 29, 2026	K263596	DLP Coronary Ostial Cannulae	Medtronic, Inc.	Minnesota	Substantially Equivalent	510(k) special	DWF	accessdata.fda.gov
October 28, 2026	K263583	Tornier Humeral Reconstruction System (HRS) Tuberosity Body	Tornier, Inc.	Minnesota	Substantially Equivalent	510(k) special	KWS	accessdata.fda.gov
October 28, 2026	K263512	Luja female	Coloplast Corp.	Minnesota	Substantially Equivalent	510(k) special	EZD	accessdata.fda.gov
October 27, 2026	P860004/S458	SynchroMed Infusion System, Ascenda Intrathecal Catheters	Medtronic, Inc.	Minnesota	Approved	PMA 180-day supplement	LKK	accessdata.fda.gov
October 27, 2026	P260019	Amplatzer Paraclose PVL Occluder	Abbott Medical	Minnesota	Approved	PMA original approval	SJT	accessdata.fda.gov
October 27, 2026	K260586	Nimbl Pneumatic Compression System	Tactile Medical	Minnesota	Substantially Equivalent	510(k) traditional	JOW	accessdata.fda.gov
October 26, 2026	P130008/S144	INSPIRE II UPPER AIRWAY STIMULATOR	Inspire Medical Systems	Minnesota	Approved	PMA real-time process supplement	MNQ	accessdata.fda.gov
October 26, 2026	K260285	Triad Hydrophilic Wound Dresssing (1964, 2.5 oz); Triad Hydrophilic Wound Dressing (1967, 6 oz)	Coloplast Corp.	Minnesota	Substantially Equivalent	510(k) traditional	FRO	accessdata.fda.gov
October 23, 2026	P980035/S848	Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG...	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	NVZ	accessdata.fda.gov
October 23, 2026	P240036/S007	OmniaSecure MRI SureScan Lead Model 3930M	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	NVY	accessdata.fda.gov
October 23, 2026	P010015/S591	Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena...	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	LWP	accessdata.fda.gov
October 23, 2026	K261792	DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent	Medtronic	Minnesota	Substantially Equivalent	510(k) traditional		accessdata.fda.gov
October 22, 2026	P130008/S147	Model 3150 IPG	Inspire Medical Systems	Minnesota	30-day notice accepted	PMA 30-day notice	MNQ	accessdata.fda.gov
October 21, 2026	P900056/S229	ROTAPRO Rotational Atherectomy System	Boston Scientific Corp	Minnesota	30-day notice accepted	PMA 30-day notice	MCX	accessdata.fda.gov
October 21, 2026	P900056/S226	ROTAPRO Rotational Atherectomy Systems	Boston Scientific Corp	Minnesota	Approved	PMA real-time process supplement	MCX	accessdata.fda.gov
October 20, 2026	P900056/S228	ROTAPRO Rotational Atherectomy System	Boston Scientific Corp	Minnesota	30-day notice accepted	PMA 30-day notice	MCX	accessdata.fda.gov
October 20, 2026	K262597	Access BNP II	Beckman Coulter, Inc.	Minnesota	Substantially Equivalent	510(k) traditional	NBC	accessdata.fda.gov
October 19, 2026	K261109	Access MeMed BV	Beckman Coulter, Inc.	Minnesota	Substantially Equivalent	510(k) traditional	QPS	accessdata.fda.gov
October 16, 2026	P860004/S462	SynchroMed Infusion System, Ascenda Intrathecal Catheters	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	LKK	accessdata.fda.gov
October 16, 2026	P200026/S019	Abre Venous Self-Expanding Stent System	Medtronic Vascular, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	QAN	accessdata.fda.gov
October 16, 2026	P110023/S069	EverFlex Self-Expanding Peripheral Stent System; EverFlex Self-Expanding Peripheral Stent with Entrust...	Medtronic Vascular, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	NIP	accessdata.fda.gov
October 16, 2026	P060001/S059	Protégé GPS Self-Expanding Peripheral Stent System; Protégé RX Self-Expanding Carotid Stent System	Medtronic Vascular, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	NIM	accessdata.fda.gov
October 16, 2026	P030045/S011	Visi-Pro balloon-Expandable peripheral stent system	Medtronic Vascular, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	NIO	accessdata.fda.gov
October 16, 2026	P030036/S162	MEDTRONIC SELECTSECURE LEAD MODEL 3830	Medtronic Cardiac Rhythm Disease Management	Minnesota	30-day notice accepted	PMA 30-day notice	NVN	accessdata.fda.gov
October 15, 2026	P250022/S002	Volt PFA System	Abbott Medical	Minnesota	Approved	PMA 180-day supplement	QZI	accessdata.fda.gov
October 15, 2026	P140018/S050	VenaSeal Closure System	Medtronic Vascular, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	PJQ	accessdata.fda.gov
October 15, 2026	P090018/S044	Esteem®	Envoy Medical Corporation	Minnesota	30-day notice accepted	PMA 30-day notice	OAF	accessdata.fda.gov
October 13, 2026	P130008/S146	Model 3150 IPG	Inspire Medical Systems	Minnesota	30-day notice accepted	PMA 30-day notice	MNQ	accessdata.fda.gov
October 9, 2026	P970004/S459	InterStim Therapy System, Verify Evaluation System	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	EZW	accessdata.fda.gov
October 9, 2026	P240013/S032	Affera Sphere-9 Mapping and Ablation Catheter	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	QZI	accessdata.fda.gov
October 9, 2026	P080025/S353	InterStim Therapy System, Verify Evaluation System	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	QON	accessdata.fda.gov
October 8, 2026	P250022/S012	VOLT PFA CATHETER, SENSOR ENABLED	Abbott Medical	Minnesota	30-day notice accepted	PMA 30-day notice	QZI	accessdata.fda.gov
October 8, 2026	P250022/S009	Volt PFA Catheter, Sensor Enabled	Abbott Medical	Minnesota	30-day notice accepted	PMA 30-day notice	QZI	accessdata.fda.gov
October 6, 2026	P970004/S457	InterStim Therapy System, Verify Evaluation System	Medtronic Neuromodulation	Minnesota	Approved	PMA real-time process supplement	EZW	accessdata.fda.gov
October 6, 2026	P960009/S542	Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense	Medtronic, Inc.	Minnesota	Approved	PMA real-time process supplement	MHY	accessdata.fda.gov
October 6, 2026	P840001/S632	Master Vanta with Restore, Itrel, Synergy, Intellis, AdaptiveStim Vanta and Inceptiv TM Spinal Cord...	Medtronic Neuromodulation	Minnesota	Approved	PMA real-time process supplement	LGW	accessdata.fda.gov
October 6, 2026	P240013/S028	Sphere-9 Catheter and Affera Ablation System	Medtronic, Inc.	Minnesota	Approved	PMA real-time process supplement	QZI	accessdata.fda.gov
October 6, 2026	P080025/S351	lnterStim Therapy System, Verify Evaluation System	Medtronic Neuromodulation	Minnesota	Approved	PMA real-time process supplement	QON	accessdata.fda.gov
October 6, 2026	K261141	OpenFlo Urinary Catheter	Urolution Medical, Inc.	Minnesota	Substantially Equivalent	510(k) traditional	EZL	accessdata.fda.gov
October 5, 2026	P980035/S847	Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT...	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	NVZ	accessdata.fda.gov
October 5, 2026	P980016/S966	Cobalt MRI ICD (DDPB3Dl, DDPB3D4, DVPB3Dl, DVPB3D4); Cobalt XT MRI ICD (DDPA2Dl, DDPA2D4, DVPA2Dl, DVPA2D4)...	Medtronic Cardiac Rhythm Disease Management	Minnesota	30-day notice accepted	PMA 30-day notice	LWS	accessdata.fda.gov
October 5, 2026	P010031/S933	Cobalt MRI CRT-D (DTPB2Dl, DTPB2D4, DTPB2Ql, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2Dl, DTPA2D4, DTPA2Ql...	Medtronic Cardiac Rhythm Disease Management	Minnesota	30-day notice accepted	PMA 30-day notice	NIK	accessdata.fda.gov
October 5, 2026	P010015/S590	Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara...	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	LWP	accessdata.fda.gov
October 3, 2026	P150012/S191	ESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331); ESSENTIO MRI (Models L110...	Boston Scientific	Minnesota	30-day notice accepted	PMA 30-day notice	LWP	accessdata.fda.gov
October 3, 2026	P030005/S257	VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Models U225, U226); VISIONIST X4 (Model U228)	Guidant Corp.	Minnesota	30-day notice accepted	PMA 30-day notice	NKE	accessdata.fda.gov
October 3, 2026	N970003/S311	ALTRUA 2 (Model S722); ESSENTIO (Model L121); PROPONENT (Model L221); ACCOLADE (Model L321); ALTRUA 2...	Boston Scientific Corp	Minnesota	30-day notice accepted	PMA 30-day notice	LWP	accessdata.fda.gov
October 2, 2026	P240013/S031	Sphere-9 Catheter and Affera Ablation System	Medtronic, Inc.	Minnesota	Approved	PMA real-time process supplement	QZI	accessdata.fda.gov
October 2, 2026	P110042/S216	EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) high voltage (HV) Capacitor	Boston Scientific Corporation	Minnesota	30-day notice accepted	PMA 30-day notice	LWS	accessdata.fda.gov
September 25, 2026	P980016/S965	Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD	Medtronic Cardiac Rhythm Disease Management	Minnesota	30-day notice accepted	PMA 30-day notice	LWS	accessdata.fda.gov
September 25, 2026	P100010/S154	STOP Persistent AF	Medtronic Cryocath, LP	Minnesota	Approved	PMA 180-day supplement	OAE	accessdata.fda.gov
September 25, 2026	P010031/S932	Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D	Medtronic Cardiac Rhythm Disease Management	Minnesota	30-day notice accepted	PMA 30-day notice	NIK	accessdata.fda.gov
September 24, 2026	P960009/S546	MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	MHY	accessdata.fda.gov
September 24, 2026	P840001/S634	Vantawith AdaptiveStim Technology - Model 977006	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	LGW	accessdata.fda.gov
September 24, 2026	P180047/S046	LIAISON® QuantiFERON®-TB Gold Plus II.	DiaSorin, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	NCD	accessdata.fda.gov
September 23, 2026	P100047/S241	HeartWare® HVAD System	Medtronic	Minnesota	Approved	PMA special supplement	DSQ	accessdata.fda.gov
September 22, 2026	P220013/S034	TactiFlex Ablation Catheter, Sensor Enabled	Abbott Medical	Minnesota	Approved	PMA 135-day supplement	OAE	accessdata.fda.gov
September 21, 2026	K262109	Access NT-proBNP	Beckman Coulter, Inc.	Minnesota	Substantially Equivalent	510(k) traditional	NBC	accessdata.fda.gov
September 18, 2026	P040021/S063	Epic Plus, Epic Plus Supra, Epic Max, Epic Elite, Epic Supra G3 Tissue Heart Valves	Abbott Medical	Minnesota	30-day notice accepted	PMA 30-day notice	LWR	accessdata.fda.gov
September 17, 2026	P910073/S193	ENDOTAK LEAD SYSTEM	Boston Scientific	Minnesota	Approved	PMA special supplement	LWS	accessdata.fda.gov
September 17, 2026	K262913	Protégé EverFlex Self-expanding Peripheral Stent System	Medtronic, Inc.	Minnesota	Substantially Equivalent	510(k) special	FGE	accessdata.fda.gov
September 17, 2026	K261729	EnSite X EP System	Abbott Medical	Minnesota	Substantially Equivalent	510(k) traditional	DQK	accessdata.fda.gov
September 16, 2026	K261467	GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)	Gt Metabolic Solutions, Inc.	Minnesota	Substantially Equivalent	510(k) traditional	SAH	accessdata.fda.gov
September 14, 2026	P970004/S458	InterStim Therapy System Verify Evaluation System	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	EZW	accessdata.fda.gov
September 14, 2026	P240011/S016	Altaviva	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	QPT	accessdata.fda.gov
September 14, 2026	P080025/S352	InterStim Therapy System, Verify Evaluation System	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	QON	accessdata.fda.gov
September 11, 2026	K254041	SkinSmart Antimicrobial HydroGel	Magic Science Supply, LLC	Minnesota	Substantially Equivalent	510(k) traditional	FRO	accessdata.fda.gov
September 8, 2026	P150033/S230	Micra Functional Testing on pNGHT and NGHT	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	PNJ	accessdata.fda.gov
September 4, 2026	P220013/S028	TactiFlex Duo Ablation Catheter, Sensor Enabled (A-TFDM-D, A-TFDM-F, A-TFDM-J, A-TFDM-DD, A-TFDM-DF...	Abbott Medical	Minnesota	Approved	PMA panel track supplement	OAE	accessdata.fda.gov
September 4, 2026	K262277	70 NeuGlide Catheter	Piraeus Medical, Inc.	Minnesota	Substantially Equivalent	510(k) special	QJP	accessdata.fda.gov
September 3, 2026	K262315	NeuroBlate System	Monteris Medical	Minnesota	Substantially Equivalent	510(k) traditional	ONO	accessdata.fda.gov
September 3, 2026	K253673	Mcare System (MW-20)	Marani Health, Inc.	Minnesota	Substantially Equivalent	510(k) traditional	LQK	accessdata.fda.gov
August 31, 2026	P240042/S004	Tendyne Transcatheter Mitral Valve System	Abbott Medical	Minnesota	30-day notice accepted	PMA 30-day notice	NPU	accessdata.fda.gov
August 28, 2026	P230035/S010	AGENT Paclitaxel-Coated Balloon Catheter	Boston Scientific Corporation	Minnesota	30-day notice accepted	PMA 30-day notice	OOB	accessdata.fda.gov
August 28, 2026	P200049/S021	Amplatzer Amulet Left Atrial Appendage Occluder	Abbott Medical	Minnesota	Approved	PMA special supplement	NGV	accessdata.fda.gov
August 28, 2026	P130013/S090	WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System; WATCHMAN FLX Pro Left Atrial...	Boston Scientific Corp	Minnesota	30-day notice accepted	PMA 30-day notice	NGV	accessdata.fda.gov
August 28, 2026	P130008/S136	Model 4063 Inspire Stimulation Lead	Inspire Medical Systems	Minnesota	Approved	PMA 135-day supplement	MNQ	accessdata.fda.gov
August 28, 2026	P130008/S123	INSPIRE II UPPER AIRWAY STIMULATOR	Inspire Medical Systems	Minnesota	Approved	PMA 135-day supplement	MNQ	accessdata.fda.gov
August 28, 2026	K262735	LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)	Medtronic, Inc.	Minnesota	Substantially Equivalent	510(k) special	MXD	accessdata.fda.gov
August 27, 2026	P180047/S045	LIAISON QuantiFERON-TB Gold III; LIAISON Control QuantiFERON-TB Gold III; LIAISON QuantiFERON-TB Gold Plus...	DiaSorin, Inc.	Minnesota	Approved	PMA real-time process supplement	NCD	accessdata.fda.gov
August 27, 2026	P180047/S043	LIAISON QuantiFERON-TB Gold Plus; LIAISON XL Control QuantiFERON-TB Gold Plus; LIAISON QuantiFERON-TB Gold...	DiaSorin, Inc.	Minnesota	Approved	PMA 180-day supplement	NCD	accessdata.fda.gov
August 27, 2026	K260751	35 Helix Guidewire	Piraeus Medical, Inc.	Minnesota	Substantially Equivalent	510(k) traditional	MOF	accessdata.fda.gov
August 26, 2026	P230021/S004	Duo Venous Stent System	Philips Image Guided Therapy Corporation	Minnesota	30-day notice accepted	PMA 30-day notice	QAN	accessdata.fda.gov
August 25, 2026	P960040/S515	Tachy Pulse Generators	Boston Scientific	Minnesota	Approved	PMA real-time process supplement	LWS	accessdata.fda.gov
August 25, 2026	P010012/S612	Tachy Pulse Generators	Boston Scientific Corp	Minnesota	Approved	PMA real-time process supplement	NIK	accessdata.fda.gov
August 24, 2026	K260604	BiWaze Clear System	Abmrc, LLC	Minnesota	Substantially Equivalent	510(k) traditional	NHJ	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
Medtronic, Inc.	444	October 30, 2026
Medtronic Neuromodulation	177	October 30, 2026
Medtronic Cardiac Rhythm Disease Management	160	October 29, 2026
Abbott Medical	142	October 29, 2026
Boston Scientific Corp	95	October 21, 2026
Boston Scientific	85	October 3, 2026
DiaSorin, Inc.	64	September 24, 2026
Boston Scientific Corporation	58	October 2, 2026
Medtronic Vascular, Inc.	47	October 30, 2026
Inspire Medical Systems	30	October 26, 2026
Medtronic	19	October 23, 2026
Coloplast Corp.	15	October 28, 2026
St Jude Medical	15	August 7, 2026
Guidant Corp.	14	October 3, 2026
Beckman Coulter, Inc.	11	October 20, 2026
Medtronic Cryocath, LP	10	September 25, 2026
Cardiovascular Systems, Inc.	8	March 10, 2026
Canon Medical Informatics, Inc.	4	October 29, 2026
Tornier, Inc.	4	October 28, 2026
Philips Image Guided Therapy Corporation	4	August 26, 2026

By panel

Panel	Decisions	Latest
Cardiovascular	1,045	October 30, 2026
Gastroenterology, Urology	156	October 29, 2026
Neurology	123	October 30, 2026
Microbiology	71	October 19, 2026
General Hospital	37	October 30, 2026
Anesthesiology	35	October 26, 2026
Orthopedic	12	October 28, 2026
Radiology	9	October 29, 2026
General, Plastic Surgery	8	September 16, 2026
Ear, Nose, Throat	5	October 15, 2026
Clinical Chemistry	4	October 20, 2026
Unknown	3	October 26, 2026
Immunology	2	December 23, 2025
Obstetrics/Gynecology	1	September 3, 2026
Clinical Toxicology	1	November 26, 2025
Physical Medicine	1	December 18, 2024

By decision type

Decision type	Decisions	Latest
PMA 30-day notice	973	October 30, 2026
PMA real-time process supplement	155	October 26, 2026
PMA 180-day supplement	130	October 29, 2026
510(k) traditional	105	October 27, 2026
PMA 135-day supplement	70	September 22, 2026
510(k) special	47	October 29, 2026
PMA special supplement	18	October 30, 2026
PMA original approval	8	October 27, 2026
PMA panel track supplement	6	September 4, 2026
De Novo	1	December 23, 2025

Where FDA publishes these decisions

CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.